Company: 

RASP-UK

RASP-UK initiative

Clinical responsibilities included:

  • Protocol Development and Adherence: Design and implement trial protocols, ensuring alignment with regulatory requirements and scientific rigor.
  • Patient Safety and Monitoring: Prioritize participant safety through regular monitoring of adverse events and adherence to Good Clinical Practice (GCP) guidelines.
  • Data Collection and Quality Control: Oversee accurate and thorough data collection, ensuring integrity and reliability in trial results.
  • Regulatory Compliance: Maintain compliance with regulatory agencies like the FDA or EMA, addressing Institutional Review Board (IRB) approvals and reporting requirements.
  • Medical Oversight: Provide clinical expertise to manage and evaluate unexpected medical issues or deviations during the trial.

Managerial Responsibilities

  • Project Planning and Coordination: Establish timelines, budgets, and resource allocation to meet trial objectives effectively.
  • Team Leadership: Manage interdisciplinary teams, including researchers, clinicians, and support staff, fostering clear communication and collaboration.
  • Site Management: Oversee trial sites, ensuring they are adequately equipped, staffed, and compliant with protocols.
  • Stakeholder Communication: Maintain transparent communication with sponsors, regulators, and institutional stakeholders, providing updates on progress and challenges.
  • Risk Management: Identify and mitigate potential risks, from participant recruitment issues to operational disruptions.
What our client said

"Niche was instrumental in constructing realistic costing models for the project. On reviewing our submission, the MRC noted that having a CRO involved inspired confidence that this many-faceted project, involving so many contributors, would be successful."

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Professor Liam Heaney

Queen's University Belfast




Project background
The RASP-UK initiative, or Refractory Asthma Stratification Programme, is a UK-based research effort designed to transform the management of severe asthma by adopting a more personalized treatment approach. Funded by the Medical Research Council (MRC), Asthma UK, and several pharmaceutical partners, the program received a combined investment of £9.6 million. It aims to address the significant unmet needs of patients with severe asthma who are poorly controlled on current therapies, accounting for nearly half of asthma-related healthcare costs in the UK. Severe asthma often resists conventional treatments, which typically involve escalating doses of corticosteroids. RASP-UK focuses on two key objectives: identifying and supporting patients who struggle with medication adherence and developing tests to optimize corticosteroid use by evaluating biomarkers that predict treatment response. The program divides patients into subgroups, such as “T2-high” (responsive to corticosteroids) and “T2-low” (non-responsive), to facilitate more targeted therapy and to explore novel treatments for resistant cases. Collaborating with UK universities, NHS severe asthma centers, and industry partners, RASP-UK integrates advanced biomarker research and innovative treatment strategies. The initiative has already identified potential biomarkers for treatment response and developed methods for monitoring adherence via technology. The findings are expected to enable safer, tailored treatments, reduce side effects, and open pathways for clinical trials of new drugs for severe asthma. The initiative is recognized as a groundbreaking step toward precision medicine in asthma care, offering hope for improved outcomes and reduced disease burden for patients with severe asthma
Delivery

Niche has been successfully managing the executive function of the RASP-UK consortium since the grant was awarded in 2014. The consortium consists of 13 clinical-academic centres, eight industry contributors and seven ancillary partners (organisations like Asthma UK) and is governed by an Executive Team. In serving RASP-UK, Niche provides regulatory, operational and oversight services in delivery of four separate work strands that currently incorporate seven clinical trials. Niche also works closely with patient groups through the RASP-UK patient input platform.

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